Kornimate/medical-research-clean huggingface dataset:
alto-100 in bipolar disorder with depression (bd-d)

Conditions: Bipolar Disorder I or II with a Major Depressive Episode

Summary: the purpose of this study is to assess antidepressant efficacy differences between alto-100 and placebo during the double-blind period in patients with bipolar disorder i or ii with current major depressive episode, when used adjunctively to a mood stabilizer, related to patient characteristics. additionally, safety, tolerability, and efficacy will be assessed in a subsequent open label treatment period.


Eligibility criteria:
inclusion criteria: * have a diagnosis of bd-i or bd-ii as well as bd-d * at baseline, taking a mood stabilizer, lithium (li) or lamotrigine (lmg) or valproic acid (vpa, any form) or combination of li + lmg or li + vpa for at least 6 weeks with no dose modifications in the past 2 weeks * willing to comply with all study assessments and procedures * must not be pregnant or breastfeeding at time of enrollment or throughout study exclusion criteria: * evidence of unstable medical condition * concurrent use of any prohibited medications or substance use disorder * diagnosed psychotic disorder (other than mania or depression) * current moderate or severe substance use disorder * has a history of hypersensitivity or allergic reaction to alto-100 or any of its components/excipients * concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device

Keywords: bipolar i bipolar ii major depressive episode
tips combined with microwave ablation in hcc patients with refractory ascites

Conditions: Liver Diseases; Portal Hypertension; Cirrhosis, Liver; Ascites; Hepatocellular Carcinoma

Summary: transjugular intrahepatic portosystemic shunt (tips) could effectively decrease portal hypertension-related complications. this study intends to evaluate the efficacy and safety of tips combined with subsequent microwave ablation in hcc patients with refractory ascites.

hepatocellular carcinoma (hcc) patients with refractory ascites (ra) have a very poor prognosis, and there are no effective treatments recommended by the guidelines. tips could downgrade the ascites and improve child-pugh scores. tips has been a common management model for ra for end-stage liver disease. there is no prospective study evaluating tips plus thermal ablation. thus, the investigators carried out this prospective, single-arm study to find out it.

Eligibility criteria:
inclusion criteria: 1. age between 18-70 years 2. diagnosis of hcc based on the european association for the study of the liver 3. tumor diameter ≤ 3cm 4. refractory ascites based on international ascites club: (a) intensive diuretics (spironolactone 400 mg/d combined with furosemide 160 mg/d) and sodium-restricted diet (\<90 mmovd) for at least 1 week have no response; (b) lack of response to diuretic therapy; (c) early recurrence of ascites within 4 weeks; (d) diuretic-induced complications. the grading of ascites was divided into mild ascites, moderate ascites, and large or gross ascites exclusion criteria: 1. congestive heart failure or severe valvular heart failure 2. uncontrolled systemic infection or inflammation 3. macroscopic vascular invasion or extrahepatic metastasis 4. severe pulmonary hypertension 5. severe renal insufficiency (except hepatogenic renal insufficiency) (6) rapidly progressive liver failure 6. diffuse malignant liver tumor 7. contrast agent allergy

Keywords: transjugular intrahepatic portosystemic shunt refractory ascites microwave ablation
dose-ranging study of quadrivalent human papillomavirus (hpv) (types 6,11,16,18) l1 virus-like particle (vlp) vaccine (v501-007)(completed)

Conditions: Papillomavirus Infections; Genital Diseases, Female

Summary: this study was conducted in 2 parts. part a was a randomized, double-blind, placebo-controlled, multicenter, sequential dose-escalating evaluation. part b was a randomized, double-blind (operating under in-house blinding procedures), placebo-controlled, multicenter, dose-ranging study.


Eligibility criteria:
inclusion criteria: * healthy females 16 to 23 years of age * not pregnant at enrollment and must have agreed to use effective contraception through month 7 of the study * lifetime history of 0 to 4 male sexual partners (individuals with whom penetrative sexual intercourse occurred) exclusion criteria: * no prior receipt of an human papillomavirus (hpv) vaccine * no receipt of inactivated or recombinant vaccines within 14 days prior to enrollment or receipt of live vaccines within 21 days prior to enrollment * no prior abnormal pap test showing squamous intraepithelial lesion (sil) or biopsy showing cervical intraepithelial neoplasia (cin) * no prior history of genital warts or treatment for genital warts

Keywords: hpv 6/11/16/18 infection and related genital disease
integration of hiv care and treatment into antenatal care in migori district, kenya

Conditions: HIV Infections

Summary: this study seeks to determine the most effective way to reach and provide pregnant women with accessible, comprehensive, and high quality hiv care and treatment.

this study uses a prospective cluster randomized design. twelve clinics similar in size, population, and services in migori district, kenya that provide anc have been randomly assigned to receive "integrated anc, pmtct \& hiv services" (intervention arm) or "non-integrated services" (control arm). at the intervention clinics, pregnant women will receive anc, pmtct and hiv care and treatment (including haart if required) at the same clinic visit from the anc provider. at the control clinics, women will receive antenatal care and pmtct services with referral to the hiv care and treatment department located in the same facility. the control sites more closely resemble the current approach followed for care and treatment of hiv-infected pregnant women in kenya. the content of anc, pmtct, and hiv care will be the same in the two study arms and will follow current kenyan national guidelines. the only difference between the two arms will be the provider/location of hiv care and treatment. outcomes will be compared for hiv-positive pregnant women who attend intervention versus control facilities. in addition we will conduct qualitative research with health care providers at the study health facilities in order to learn provider perspectives on the two service models and to explore the effects of integration on provider job satisfaction (including work load).

Eligibility criteria:
inclusion criteria: * for site inclusion: * each site must provide anc services * each site must provide hiv testing services for pregnant women * each site must have an average of at least 20 new anc clients per month * for enrollment of hiv-positive women: * all women testing hiv-positive at one of the 12 anc clinics included in the study will be asked to participate in the study * for health provider inclusion in interviews: * health care staff must work within the anc clinic at selected facilities * staff must be able to read and speak english well enough to complete the informed consent process, participate in a one-on-one in-depth interview in english and complete a brief self-administered questionnaire exclusion criteria: * for site exclusion: * if all of inclusion criteria are not met the site will be excluded * if site is already providing integrated anc/hiv care services * for health provider inclusion in interviews: * if all of inclusion criteria are not met the site will be excluded

Keywords: pmtct vertical transmission of hiv pregnant women infant hiv testing kenya aids
an observational study of patients with malignant lymphomas treated with mabthera® sc in everyday clinical practice

Conditions: Lymphoma, B-Cell, Lymphoma, Follicular

Summary: this observational study aims to assess the therapeutic responsiveness of mabthera sc in patients with malignant lymphomas under everyday clinical practice conditions. patients with previously untreated cd-20 positive follicular non-hodgkin's lymphoma (nhl) or previously untreated cd-20 positive diffuse large b-cell lymphoma (dlbcl) who are planned for therapy with mabthera sc according to the assessment of the physician will be prospectively enrolled for observation. no study specific measures are required; treatment and documentation will be performed according to usual clinical practice.


Eligibility criteria:
inclusion criteria: * women and men aged \>=18 years * previously untreated cd-20 positive follicular nhl * previously untreated cd-20 positive dlbcl * planned therapy with mabthera sc according to the assessment of the physician (before the start and independent from this study) * suitability for the therapy with mabthera sc exclusion criteria: all contraindications, interactions and incompatibilities for therapy with mabthera sc
the effect of the covid-19 pandemic among operated patients

Conditions: Covid19; Surgery

Summary: this project covers several research aims. in a cohort study, the investigators aim to compare confirmed covid-19 patients with non-covid-19 patients who undergo surgical treatment and study factors associated with good or bad outcomes.

background a novel coronavirus (sars-cov-2) was first detected in the hubei province in china in december, 2019. the virus causes a severe respiratory disease (coronavirus disease 2019, covid-19) that has rapidly spread worldwide. the covid-19 pandemic is prognosed to affect a majority of the world's population before the end of 2020. throughout the course of the pandemic, patients will continuously need essential healthcare, such as for acute surgical conditions. how the clinical course and management of surgical conditions is influenced by concomitant covid-19 is largely unknown. there is an acute need for an improved evidence base to inform treatment strategies and guide the management of this patient group. objectives of initial analyses 1. to compare confirmed covid-19 patients with non-covid-19 patients who undergo surgical treatment and study factors associated with good or bad outcomes. methods the study will enroll consecutive patients that undergo surgical treatment in the stockholm region. data will be extracted from a series of linked electronic systems, such as electronic healthcare records systems, and regional data systems. collected data will include routine clinical data, such as baseline characteristics, previous medical history, details on care given at the hospital and data from follow-up visits. endpoints include death, length of hospital stay and complications, such as readmission, reoperation, sepsis, respiratory failure, and number of days in the intensive care unit. outcome data of patients with confirmed covid-19 will be compared to those of patients without covid-19. dissemination and relevance to the best of the investigators knowledge, there has been no previous comprehensive comparative research on patients with and without confirmed covid-19 that undergo surgical treatment. the results will be disseminated through peer-reviewed publications, aiming for journals with a rapid editorial process, preferably open access journals. the findings are expected to increase the knowledge to establish best-treatment strategies and improve outcomes, both for patients affected by covid-19 and by future epidemics.

Eligibility criteria:
inclusion criteria: * patients that undergo surgical treatment in the stockholm region during the study period exclusion criteria: -
a multidisciplinary approach to vocal cord dysfunction: a novel pilot study

Conditions: Vocal Cord Dysfunction

Summary: vocal cord dysfunction (vcd) is characterized by involuntary closure of the vocal cords while inhaling. children and adolescents with vcd may experience multiple symptoms, including difficulty breathing, coughing, wheezing, neck tightness, and voice changes. there is limited information on optimal management of vcd. in our proposed study, we will use cognitive-behavioral therapy (cbt) techniques to change how patients respond to their vcd symptoms. measurements of airflow during breathing as well as symptom frequency and intensity will be examined prior to and following a series of four therapy sessions with a clinical psychologist that are focused on teaching patients strategies to decrease symptom reactivity.


Eligibility criteria:
inclusion criteria: * adolescent patients presenting to west virginia university, charleston division sub-specialty clinic for pediatric pulmonology with a clinical diagnosis of vocal cord dysfunction. * diagnosed with vcd within 12 months prior to study enrollment. between the ages of 13 and 18 years old. * currently symptomatic for vcd. * must have a baseline pft to reference at the time of diagnosis. additionally in patients who were diagnosed with vcd 6 months or more prior to study enrollment, current pft results as part of routine care, are required. * a parent or guardian must agree to participate in the four behavioral therapy sessions with his or her child. exclusion criteria: * severe psychiatric disorders (ex. psychosis, suicidal ideation) * developmental delay * previous speech therapy for the treatment of vcd. * currently receiving psychological counseling. * in open child protective services cases.

Keywords: paradoxical vocal fold motion cognitive-behavioral therapy
efficacy of ceramic soft tissue trimming bur versus conventional scalpel technique in ginigival depigmentation procedure

Conditions: Hyperpigmentation

Summary: the investigator compares the clinical outcomes and pain levels after gingival depigmentation by ceramic soft tissue bur vs scalpel surgery

this clinical study will be carried out to compare the efficacy of ceramic soft tissue trimming bur versus the conventional surgical scraping technique in the management of gingival hyperpigmentation. this study will be conducted to assess: primary objectives: 1. clinical outcome of the gingival depigmentation procedure. 2. assessment of postoperative pain using the visual analogue scale. 3. patients' satisfaction will be assessed using the patient satisfaction questionnaire (short-form, psq-18) and the global aesthetic improvement scale. secondary objectives: 1. operating time. 2. wound healing.

Eligibility criteria:
inclusion criteria: * males and females within age range of 20-50 years. * systemic (medically) free individuals. * gingival pigmentation score \> 3 on hedin melanin index15. * patients with good oral hygiene. * patients with thick gingival phenotype. exclusion criteria: * smokers. * teeth with compromised periodontium. * pregnant and lactating females. * the vulnerable group: patients with mental or physical disabilities. * medications that cause gingival pigmentation. * pathologies that cause gingival pigmentation.
compas low-waz rct mali

Conditions: Acute Malnutrition in Infancy; Acute Malnutrition in Childhood; Underweight

Summary: admissions criteria which treat children with only low mid-upper arm circumference (muac) or children with low weight-for-height z-score (whz) are not aligned with the evidence on which children are at risk of mortality. an analysis of community-based cohort data from senegal found that a combination of weight-for-age z-score (waz) and muac criteria identified all children at risk of near-term death associated with severe anthropometric deficits. this finding has led to the suggestion that waz\<-3 could be added as an independent admissions criterion for therapeutic feeding programs currently admitting children with muac\<125 mm. however, there is little evidence to inform the debate about whether children with muac ≥125 mm and waz\<-3 would benefit from treatment and, if so, what treatment protocol should be used. this study will address whether children with waz \<-3 but muac ≥125 mm benefit from therapeutic feeding and whether a simplified protocol is at least as effective as the more complicated weight-based standard protocol for this population. the study will be a prospective, multi-center, individually randomized controlled trial (rct). children aged 6-59 months presenting with muac ≥125 mm and waz\<-3 will be randomized to one of three study arms. the primary objective of this study is to assess whether therapeutic feeding with a simplified protocol (1 sachet rutf/day) results in superior nutritional outcomes compared to no therapeutic feeding and non-inferior nutritional outcomes compared to the whz and weight based dosing regimen currently used in cmam treatment 2 months after diagnosis among children aged 6-59 months with muac ≥125 mm and waz\<-3 . the primary outcome is the mean waz of children. secondary outcomes include a) proportion of children with waz \<-3, b) mean muac of children, c) proportion of children with muac \< 125 mm, d) mean whz, mean haz, e) proportion of children with whz\<-3 or haz\<-3, f) change in waz, muac, whz, haz from enrolment to endpoint g) mean skinfold thickness measure.


Eligibility criteria:
inclusion criteria: * age between 6 and 59 months * muac ≥125 mm * waz \<-3 * living in the study catchment area * expects to be able to continue follow-up visits for next 6 months exclusion criteria: * nutritional edema * known peanut or milk allergy * severe illnesses requiring inpatient level treatment (according to imci guidelines) * medical condition affecting food intake (lip and palate cleft, handicap etc.) * has already taken part in the study

Keywords: wasting stunting underweight malnutrition ready-to-use therapeutic food acute malnutrition randomized controlled trial weight-for-age z-score mid-upper-arm circumference mali
angiotensin ii receptor blockers (arb) and ace inhibitors (acei) on silent brain infarction and cognitive decline

Conditions: Brain Infarction; Hypertension

Summary: the purpose of this study is to elucidate whether or not angiotensin ii receptor blockers (arb) are more beneficial or equal to angiotensin converting enzyme inhibitors (acei) on development or progression of silent brain infarction and cognitive decline in japanese patients with essential hypertension in the elderly.

hypertension plays a major role in the development of cardiovascular diseases. treating hypertension has been associated with reduction in the risk of stroke and myocardial infarction. angiotensin converting enzyme inhibitor (acei), ramipril, showed a 32 % in relative risk of reduction in the heart outcomes prevention evaluation (hope) trial. angiotensin ii receptor blocker (arb), losartan, also showed a 25 % in relative risk of reduction in the losartan intervention for endpoint reduction in hypertension study (life). elderly people, especially hypertensive patients, with silent brain infarction have an increased risk of stroke and cognitive decline. however, no reports are seen on comparison of the effects of arbs and aceis on progression of silent brain infarction and cognitive decline in patients with essential hypertension in the elderly. the researchers therefore longitudinally evaluate silent brain infarction using magnetic resonance imaging and cognitive decline by mini-mental state examination twice at an interval of 2 years in patients with essential hypertension in the elderly who are received antihypertensive therapy by arb or acei.

Eligibility criteria:
inclusion criteria: * patients with essential hypertension (systolic blood pressure\>=140 mmhg and/or diastolic blood pressure\>=90, or treated with antihypertensive drugs) * patients with any finding of stroke, silent brain infarction, and white matter lesion on magnetic resonance imaging exclusion criteria: * secondary hypertension * atrial fibrillation * history or signs of cerebral disorders other than cerebrovascular disease * malignant tumor * chronic renal failure * severe congestive heart failure * hyperkalemia * stenosis of bilateral renal artery

Keywords: silent brain infarction cognitive decline angiotensin ii type 1 receptor blockers angiotensin-converting enzyme inhibitors hypertension
low-dose naltrexone for bladder pain syndrome

Conditions: Bladder Pain Syndrome; Interstitial Cystitis

Summary: interstitial cystitis/bladder pain syndrome (ic/pbs) is a constellation of symptoms of pelvic discomfort that includes both bladder-related pain as well as urinary frequency, urgency, and nocturia in the absence of an identifiable etiology that affects likely more than 5.4 million patients in the united states. there is a significant overlap in patients with ic/pbs and those with fibromyalgia and chronic pelvic pain syndrome. low-dose naltrexone (ldn) has been shown to be effective for the treatment of chronic pain conditions. the primary aim of this study is to evaluate if ldn improves pain scores and lower urinary tract symptoms in patients with ic/pbs. a secondary aim is to show that it has a low adverse event profile.


Eligibility criteria:
inclusion criteria: * men and women with non-hunner and hunner lesion disease * meeting aua definition of bps: an unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder associated with lower urinary tract symptoms of greater than 6 weeks duration in the absence of infection or other identifiable cause. * stable treatment for 1 month * 7-day maximum of pain scores at least 4/10 on the numerical rating scale of pain in the bladder/pelvic area. urinary frequency 8 or higher while awake. nocturia 2 or higher. bpic-ss 19. * agreement to not take opioids through the duration of the trial exclusion criteria: * substance use disorder diagnosis including opioid use disorder diagnosis * known allergy to naltrexone or naloxone * participation in another clinical trial * current or planned pregnancy, or breastfeeding * chronic pain in another location of the body that is more severe than that related to bps. * any intravesical instillation in last 8 weeks * if on elmiron, stable dose for last 3 months * if on amitriptyline, stable dose for last 3 months * any botox within last 6 months * treatment for hunners in the last 6 months * any new interstim settings within last 3 months * any new pelvic floor physical therapy in last 12 weeks * any change in or new otc meds over last 2 months. * any pain interventions in the preceding 6 weeks (epidural steroid injection, sympathetic block, peripheral nerve block, lumbar medial branch blocks) * opioids chronically for ic/bps in the past unless have been off for 1 year * recent short-term (within one week of enrollment) opioid use for flairs * no documented cystoscopy in the last 5 years